The acute mortality rate of acute myocardial infarction (AMI) reduced significantly due to emergency reperfusion and subsequent treatment strategies. However, it remains a major cause of disability and death globally. Recent studies have shown that systemic inflammation is associated with infarct size and adverse clinical outcomes after myocardial infarction. Therefore, attenuating the inflammatory response may be a therapeutic target for acute coronary syndromes and improve clinical outcomes. Preclinical and clinical data indicate that vagus nerve stimulation (VNS) plays an important role in reducing the inflammatory burden and improving myocardial ischemia. However, more clinical evidence is needed to elucidate the role of VNS in patients with acute myocardial infarction and its impact on cardiovascular events. Therefore, this study aims to investigate the effect of vagal nerve modulation intervention through a prospective, randomized controlled clinical research method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
278
The stimulation times are fixed between 07:00-09:00 in the morning and 19:00-21:00 in the evening, with an interval of 12 hours between the two sessions. The device is set with a pulse width of 200 microseconds and a pulse frequency of 20 hertz. The stimulation intensity is individually adjusted to above the perception threshold and below the discomfort level of 1 milliampere.
Vagus nerve stimulation is delivered through a transcutaneous electrical nerve stimulation device by attaching an ear clip to the tragus. But no stimulation will be delivered. The sham stimulation will be performed twice daily, each session lasting for half an hour. The stimulation times are fixed between 07:00-09:00 in the morning and 19:00-21:00 in the evening, with an interval of 12 hours between the two sessions.
The occurrence of composite cardiovascular events at 3 months
The composite cardiovascular events including recurrent myocardial infarction，acute heart failure, ventricular arrhythmia(ventricular tachycardia,flutter and fibrillation), cardiovascular death.
Time frame: 3 months after the onset of AMI
The occurrence of recurrent myocardial infarction, acute heart failure, ventricular arrhythmias, embolic events, and death at 3 months.
Separate occurrence of recurrent myocardial infarction, heart failure, ventricular arrhythmias, cardiovascular death
Time frame: 3 month after the onset of AMI
Changes in left ventricular ejection fraction (EF) at 3 months.
Left ventricular ejection fraction will be calculated by cardiac echocardiography using Simpson method
Time frame: 3 month after onset of AMI
Changes in BNP, IL-6, CRP and troponin-T on day 7.
Changes in BNP, IL-6, CRP and troponin-T on day 7. The changes will be calculated compared with baseline(immediate result after AMI).
Time frame: Day 7 after AMI
Changes in the 6-minute walk test at 3 month
6-minute walk test will performe at Day 7 and 3 month,and changes will be calculated.
Time frame: 3 months after the onset of AMI
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